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PageIntroductory material on in vitro diagnostic (IVD) medical devices
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Reference materialDefinitions of terms and links to other information about the regulation of IVDs.
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Reference materialThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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PageAn overview on Australia's regulatory framework for medical devices, including in vitro diagnostics (IVD) medical devices.
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PublicationsThe use Global Medical Device Nomenclature (GMDN) codes for in vitro diagnostic medical devices supplied in Australia.
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Reference materialInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.
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PageLaboratory-specific information for the regulation of IVDs.
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PageRegulatory information and requirements of nutrigenetic tests supplied in Australia.
In vitro diagnostic (IVD) medical devices
Links to information on in vitro diagnostic (IVD) medical devices, including HIV and nutrigenetic tests.